Project Engineer – Sligo
GerTEK Project Management & Technical Services is seeking to recruit an experienced Project Engineer to join our team in Sligo.
Primary Function and Objectives:
· To manage capital engineering projects Solid Dose (OSD) experience – Drug Product facility & equipment design/installation/commissioning
· To support the Engineering team with the emphasis on continual operational Improvements
· To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, troubleshooting, and installing/commissioning equipment.
· To provide engineering support and technical trouble shooting to all site operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives.
· Leadership of process equipment commissioning and validation activities.
· Identification and project management of continuous improvement projects.
· Work closely with all site functions and other departments to deliver these continuous improvement projects.
· Preparation of feasibility studies and budget management for all assigned projects.
· Management and negotiation of external contracts and contractors.
· Support all major site initiatives and sites core goals.
· Manage department finances within the annual organizational plan.
· Degree in a relevant engineering discipline strong experience in pharmaceutical and/or biopharma site experience of API, Drug Product, Cleanroom processing/utilities, etc.
· Knowledgeable/competent with change control Experience in process engineering, with relevant experience of batch processing, automation, project management, commissioning and validation, equipment reliability and continuous improvement. Working knowledge of distributed control systems, such as Delta V.
· This is a hands-on role requiring a logical and structured approach to resolving day today engineering issues typical of a live manufacturing environment.
· Knowledge of cGMP and regulatory requirements relating to the Healthcare industry is required.
Education and Experience Required:
· Bachelor’s Degree in Engineering or equivalent discipline.
· Drug Product Facility & Equipment Design experience
· Oral solid dose experience essential.
· 3 years relevant experience in Engineering.
3 years Project Management experience.
· Material Handling equipment – post hoists, blenders, etc
· Tablet Press expertise (Fette tablet press)
· Containment valves / downflow booth / isolators, etc